NCT03439293

A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

A Phase 2, Open-Label Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the percentage of participants with a response of very good partial response (VGPR) or better to IDd treatment.

Detailed description

The regimen being tested in this study is the combination of ixazomib, daratumumab, and dexamethasone. This study will look at the efficacy and safety of IDd in people who have RRMM. The study will enroll approximately 60 Participants. Participants will be assigned to the treatment group: • Ixazomib 4.0 mg + Daratumumab 16.0 mg/kg + Dexamethasone 20 mg All participants will be asked to take Ixazomib on Days 1, 8 and 15 of each 28-day cycle plus Daratumumab on Days 1, 8, 15 and 22 of each 28-day cycle for Cycles 1 and 2, on Days 1 and 15 of each 28-day cycle for Cycles 3 through 6 and on Day 1 of each 28-day cycle for Cycle 7 and beyond plus Dexamethasone orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle. This multi-center trial will be conducted in the United States, Czech Republic, France, Poland, Greece and the Netherlands. The overall time to participate in this study is approximately 5 years. Participants will make multiple visits to the clinic, and every 12 weeks after PD until death or termination of the study by the sponsor.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	Ixazomib capsule.
DRUG	Daratumumab	Daratumumab IV infusion.
DRUG	Dexamethasone	Dexamethasone tablets.

Timeline

• Start date: 2018-03-13
• Primary completion: 2022-01-01
• Completion: 2023-06-26
• First posted: 2018-02-20
• Last updated: 2024-07-03
• Results posted: 2023-02-08

Locations

28 sites across 6 countries: United States, Czechia, France, Greece, Netherlands, Poland

Regulatory

• FDA-regulated drug study